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Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid

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An Erratum to this article was published on 10 June 2014

Abstract

Purpose

This analysis evaluated patient-reported outcomes and analgesic use in patients with bone metastases from solid tumours across three comparative studies of denosumab and zoledronic acid.

Methods

Pooled data were analysed from three identically designed double-blind phase III studies comparing subcutaneous denosumab 120 mg with intravenous zoledronic acid 4 mg monthly in patients with bone metastases from breast cancer (n = 2,046), castration-resistant prostate cancer (n = 1,901) or other solid tumours (n = 1,597). Pain severity, pain interference, health-related quality of life and analgesic use were quantified.

Results

At baseline, approximately half of patients had no/mild pain (53 % [1,386/2,620] denosumab; 50 % [1,297/2,578] zoledronic acid). Denosumab delayed onset of moderate/severe pain by 1.8 months (median, 6.5 vs 4.7 months; hazard ratio, 0.83; 95 % CI, 0.76–0.92; p < 0.001; 17 % risk reduction) and clinically meaningful increases in overall pain interference by 2.6 months (median, 10.3 vs 7.7 months; hazard ratio, 0.83; 95 % CI, 0.75–0.92; p < 0.001; 17 % risk reduction) compared with zoledronic acid. Strong opioid use and worsening of health-related quality of life were less common with denosumab.

Conclusions

Across three large studies of patients with advanced solid tumours and bone metastases, denosumab prevented progression of pain severity and pain interference more effectively than zoledronic acid.

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Acknowledgements

This work was supported by Amgen Inc. Jonathan Latham (whose work was funded by Amgen Inc.) and Vidya S. Beckman of Amgen Inc. provided medical writing assistance in the preparation of the manuscript.

Disclosures

The authors disclose the following potential conflicts of interest. Consultant—Amgen (RvM, JJB, AS, JEB, LJF, GM, CSC and DLP); Novartis (RvM, JJB, AS and JEB); Roche (RvM) and Bristol Myers Squibb (JEB). Remuneration—Amgen (RvM, JJB, JEB, LJF and GM); Novartis (RvM and JJB) and Roche (RvM). Funding—Amgen (RvM and JEB); Roche (RvM) and Novartis (JEB). Employment and stock ownership—Amgen (YQ, AB and KC).

Author information

Authors and Affiliations

  1. Kantonsspital Graubünden, Loëstrasse 170, 7000, Chur, Switzerland

    Roger von Moos

  2. Chu Brugmann, Université Libre De Bruxelles, Brussels, Belgium

    Jean-Jacques Body

  3. Urology Associates/Urologic Medical Research, Kitchener, ON, Canada

    Blair Egerdie

  4. Arizona Cancer Center, University of Arizona, Tucson, AZ, USA

    Alison Stopeck

  5. Cancer Research UK Experimental Cancer Medicine Centres, Leeds and Sheffield, UK

    Janet E. Brown

  6. National Hospital for Treatment in Oncology, Sofia, Bulgaria

    Danail Damyanov

  7. Sussex Health Outcomes Research & Education in Cancer (SHORE-C), University of Sussex, Brighton, UK

    Lesley J. Fallowfield

  8. Sydney Adventist Hospital, University of Sydney, Sydney, NSW, Australia

    Gavin Marx

  9. University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Charles S. Cleeland

  10. University of Washington, Seattle, WA, USA

    Donald L. Patrick

  11. CAIPO, San Miguel de Tucuman, Argentina

    Felipe G. Palazzo

  12. Amgen Inc., Thousand Oaks, CA, USA

    Yi Qian, Ada Braun & Karen Chung

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  1. Roger von Moos
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Corresponding author

Correspondence to Roger von Moos.

Additional information

Portions of this work were presented at the European Oncology Nursing Society (EONS) 8th Spring Convention, 26–27 April 2012 in Geneva, Switzerland.

Trial Registration: The three studies are registered at www.clinicaltrials.gov as NCT00321464, NCT00321620 and NCT00330759.

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von Moos, R., Body, JJ., Egerdie, B. et al. Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid. Support Care Cancer 21, 3497–3507 (2013). https://doi.org/10.1007/s00520-013-1932-2

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  • DOI: https://doi.org/10.1007/s00520-013-1932-2

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